Global Regulatory Affairs Manager
- Sanand, Gujarat
- Permanent
- Full-time
Duties and Responsibilities:
- Responsible for strategic development, implementation, maintenance, and overall success of the company’s regulatory project approvals in different countries.
- Develop, implement, and support a comprehensive regulatory compliance strategy to meet global market requirements for our products and ensure alignment with our overall business strategy.
- Regulatory affairs strategy and coordination with Internal and external team for Asia, Africa, ANZ, Middle East, Europe and LATAM countries.
- Coordinate with the Sales & Marketing team for business continuity and center of contact for all regulatory matters.
- Regulatory compliance and medical device registration in Asia, Africa, ANZ, Middle East, Europe and LATAM countries. Management of a team of RA coordinators for different countries.
- Manage post approval changes in Global market for all products
- Ensure that regulated processes and systems are always inspection ready.
- Draft, review, edit, and maintain all departmental policies and procedures, including Post approval changes, regulatory review of order, label and IFU requirements, Language translation needs, Marketing claims etc.
- Manage, train and guide the team members as and when required.